Item 1.01 Entry into a Material Definitive Agreement.
On November 16, 2021, Mirum Pharmaceuticals, Inc. (the "Company") entered into
an asset purchase agreement (the "Agreement") with Janssen Biotech, Inc.
("Buyer"), an affiliate of Johnson & Johnson, pursuant to which the Company
agreed to sell its Rare Pediatric Disease Priority Review Voucher ("PRV") to
Buyer. The Company was awarded the PRV by the U.S. Food and Drug Administration
on September 29, 2021 in connection with the approval of LIVMARLI™ (maralixibat)
oral solution for the treatment of cholestatic pruritus in patients with
Alagille syndrome (ALGS) one year of age and older. Pursuant to the Agreement,
Buyer agreed to pay the Company $110.0 million, payable in cash, upon the
closing of the PRV purchase.
The Agreement contains customary representations, warranties, covenants and
indemnification provisions subject to certain limitations. The transaction
remains subject to customary closing conditions, including the expiration or
termination of the applicable waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976.
The foregoing description of the material terms of the Agreement does not
purport to be complete and is qualified in its entirety by reference to the
complete text of the Agreement, a copy of which is filed herewith as Exhibit
10.1 and incorporated herein by reference.
This Current Report on Form 8-K (this "Current Report") contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this Current Report that do not relate to
matters of historical fact should be considered forward-looking statements,
including without limitation statements regarding the completion of the
transactions contemplated by the Agreement. Statements using words such as
"expect", "anticipate", "believe", "may", "will" and similar terms are also
forward-looking statements. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and other
important factors that may cause the Company's actual results, performance or
achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements, including,
but not limited to, the important factors discussed under the caption "Risk
Factors" in the Company's most recently filed Quarterly Report on Form 10-Q and
the Company's other filings with the Securities and Exchange Commission. Except
as required by law, the Company undertakes no obligations to make any revisions
to the forward-looking statements contained in this Current Report or to update
them to reflect events or circumstances occurring after the date of this Current
Report, whether as a result of new information, future developments or
Item 9.01 Financial Statements and Exhibits.
Exhibit No. Description
10.1¥ Asset Purchase Agreement, dated November 16, 2021, by and
between the Registrant and Janssen Biotech, Inc.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
¥ Schedules have been omitted pursuant to Item 601(a)(5) of
Regulation S-K. The registrant undertakes to furnish supplemental
copies of any of the omitted schedules upon request by the SEC.
© Edgar Online, source Glimpses